DOCSLIB.ORG

Transdermal and Topical Delivery Systems - Product Development and Quality Considerations

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document, contact (CDER) Mohamed Ghorab 240-402-8940. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) November 2019 Pharmaceutical Quality/CMC 14981899 Dft Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: [email protected] https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) November 2019 Pharmaceutical Quality/CMC Contains Nonbinding Recommendations Draft — Not for Implementation TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 1 A. General ............................................................................................................................................ 1 B. Regulatory Status ........................................................................................................................... 3 III. TDS PRODUCT DEVELOPMENT ................................................................................ 4 A. Quality Target Product Profile ..................................................................................................... 4 B. Critical Quality Attributes ............................................................................................................ 5 1. TDS Product .................................................................................................................................... 5 2. Drug Substance ................................................................................................................................ 5 3. Excipients and Components ............................................................................................................. 6 4.Identifying Labeling .......................................................................................................................... 7 C. Product and Process Development ............................................................................................... 7 IV. INFORMATION TO BE SUBMITTED IN AN APPLICATION ............................... 8 A. Pharmaceutical Development ....................................................................................................... 8 1. Batch Formula ............................................................................................................................... 10 2. Expectations for Registration/Exhibit Batches .............................................................................. 10 3. Product Characterization Studies .................................................................................................. 11 4. Proposed Manufacturing Changes ................................................................................................ 16 B. Manufacture ................................................................................................................................. 17 C. Control of TDS Product .............................................................................................................. 19 D. Additional Stability Studies ........................................................................................................ 24 V. SPECIAL TOPICS ......................................................................................................... 24 A. Product Adhesion Considerations .............................................................................................. 24 B. Product Storage and Disposal – Labeling Considerations ....................................................... 25 Contains Nonbinding Recommendations Draft — Not for Implementation 1 Transdermal and Topical Delivery Systems - Product Development 2 and Quality Considerations 3 Guidance for Industry1 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 I. INTRODUCTION 15 16 This guidance provides recommendations to applicants and manufacturers of transdermal and 17 topical delivery systems (TDS)2 regarding the pharmaceutical development and quality 18 information to include in new drug applications (NDAs) and abbreviated new drug applications 19 (ANDAs).3,4 Specifically, the guidance discusses FDA’s current thinking on product design and 20 pharmaceutical development, manufacturing process and control, and finished product control. It 21 also addresses special considerations for areas where quality is closely tied to product 22 performance and potential safety issues, such as adhesion failure and the impact of applied heat 23 on drug delivery. 24 25 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 26 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 27 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 28 the word should in Agency guidances means that something is suggested or recommended, but 29 not required. 30 31 II. BACKGROUND 32 33 A. General 34 1 This guidance has been prepared by the Office of Pharmaceutical Quality and Office of Generic Drugs in the Center for Drug Evaluation and Research, in consultation with the Center for Devices and Radiological Health, and the Office of Combination Products, at the Food and Drug Administration. 2 For the purpose of this guidance, both transdermal and topical delivery systems are referred to by the acronym “TDS.” 3 Some TDS (such as microneedles, active transport TDS, reservoir TDS, and TDS applied to broken skin) have other considerations that are not addressed in this guidance. 4 The general principles in this guidance can also be applied to nonapplication drug products; for example, over-the- counter drugs products marketed under the monograph regulatory construct (see 21 CFR part 330). 1 Contains Nonbinding Recommendations Draft — Not for Implementation 35 Transdermal delivery systems are designed to deliver an active ingredient (drug substance) 36 across the skin and into systemic circulation, while topical delivery systems are designed to 37 deliver the active ingredient to local tissue.5 Both delivery systems present similar manufacturing 38 and quality control concerns and similar risks to patients. TDS can be broadly divided into 39 matrix type and liquid or gel reservoir type delivery systems. 40 41 Matrix type TDS contain one or more active ingredients dissolved or partially suspended in a 42 mixture of various components, including adhesives, penetration enhancers, softeners, and 43 preservatives, and are typically manufactured using solvent, hydrogel, or hot melt-based 44 practices. An example of a matrix type TDS is shown in Figure 1, but matrix TDS may include 45 additional layers and/or more complex designs. 46 47 Figure 1. Matrix Type Transdermal or Topical Delivery System 48 49 50 51 Reservoir type TDS similarly contain a variety of components in liquid or semi-solid form; 52 however, reservoir type TDS utilize a heat-sealed area to entrap the active gel between the 53 backing membrane and a microporous membrane. An example of a reservoir type TDS is shown 54 in Figure 2. Because of the inherent failure modes and safety risks associated with the reservoir 55 TDS, FDA recommends TDS manufacturers and applicants focus development efforts on matrix 56 type TDS.6 57 5 Topically administered liquid and semi-solid drug products without a carrier device (e.g., gels, creams, lotions, foams, ointments, or sprays) are not considered to be TDS and are not covered by this guidance, even though they can be formulated to provide local, or in some cases, transdermal delivery of the drug. 6 Applicants are strongly encouraged to consult the Office of Pharmaceutical Quality early in the development process prior
Load more

Recommended publications
  • Transdermal Absorption Preparation
    Europäisches Patentamt *EP001522316A1* (19) European Patent Office Office européen des brevets (11) EP 1 522 316 A1 (12) EUROPEAN PATENT APPLICATION published in accordance with Art. 158(3) EPC (43) Date of publication: (51) Int Cl.7: A61K 47/34, A61K 47/10, 13.04.2005 Bulletin 2005/15 A61K 47/14, A61K 9/06, A61K 9/08, A61K 9/12, (21) Application number: 03764126.3 A61K 9/70 (22) Date of filing: 02.07.2003 (86) International application number: PCT/JP2003/008400 (87) International publication number: WO 2004/006960 (22.01.2004 Gazette 2004/04) (84) Designated Contracting States: • OMICHI, Katsuhiro AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Saitama-shi, Saitama 338-0832 (JP) HU IE IT LI LU MC NL PT RO SE SI SK TR • OKADA, Minoru Designated Extension States: Inzai-shi, Chiba 270-1323 (JP) AL LT LV MK • KURAZUMI, Toshiaki Narita-shi, Chiba 286-0011 (JP) (30) Priority: 16.07.2002 JP 2002206565 (74) Representative: Hartz, Nikolai F., Dr. (71) Applicant: SSP Co., Ltd. Wächtershäuser & Hartz Chuo-ku, Tokyo 103-8481 (JP) Patentanwälte Weinstrasse 8 (72) Inventors: 80333 München (DE) • NARUI, Takashi Sakura-shi, Chiba 285-0817 (JP) (54) TRANSDERMAL ABSORPTION PREPARATION (57) A transdermal absorption promotion composi- and transdermal absorption preparation not only exhibit tion comprising the following components (a), (b), and an excellent transdermal absorption promotion effect, (c) and a transdermal absorption preparation compris- but also exhibit superior skin-permeability, even if a drug ing the following components (a), (b), (c), and (d) are having a relatively high lipophilic property and poor disclosed.
    [Show full text]
  • An Introduction to Fast Dissolving Oral Thin Film Drug Delivery Systems: a Review
    Muthadi Radhika Reddy /J. Pharm. Sci. & Res. Vol. 12(7), 2020, 925-940 An Introduction to Fast Dissolving Oral Thin Film Drug Delivery Systems: A Review Muthadi Radhika Reddy1* 1School of pharmacy, Gurunanak Institute of Technical Campus, Hyderabad, Telangana, India and Department of Pharmacy, Gandhi Institute of Technology and Management University, Vizag, Andhra Pradesh, India INTRODUCTION 2. Useful in situations where rapid onset of action Fast dissolving drug delivery systems were first developed required such as in motion sickness, allergic attack, in the late 1970s as an alternative to conventional dosage coughing or asthma forms. These systems consist of solid dosage forms that 3. Has wide range of applications in pharmaceuticals, Rx disintegrate and dissolve quickly in the oral cavity without Prescriptions and OTC medications for treating pain, the need of water [1]. Fast dissolving drug delivery cough/cold, gastro-esophageal reflux disease,erectile systems include orally disintegrating tablets (ODTs) and dysfunction, sleep disorders, dietary supplements, etc oral thin films (OTFs). The Centre for Drug Evaluation [4] and Research (CDER) defines ODTs as,“a solid dosage 4. No water is required for the administration and hence form containing medicinal substances which disintegrates suitable during travelling rapidly, usually within a matter of seconds, when placed 5. Some drugs are absorbed from the mouth, pharynx upon the tongue” [2]. USFDA defines OTFs as, “a thin, and esophagus as the saliva passes down into the flexible, non-friable polymeric film strip containing one or stomach, enhancing bioavailability of drugs more dispersed active pharmaceutical ingredients which is 6. May offer improved bioavailability for poorly water intended to be placed on the tongue for rapid soluble drugs by offering large surface area as it disintegration or dissolution in the saliva prior to disintegrates and dissolves rapidly swallowing for delivery into the gastrointestinal tract” [3].
    [Show full text]
  • An Overview On: Sublingual Route for Systemic Drug Delivery
    International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701 __________________________________________Review Article An Overview on: Sublingual Route for Systemic Drug Delivery K. Patel Nibha1 and SS. Pancholi2* 1Department of Pharmaceutics, BITS Institute of Pharmacy, Gujarat Technological university, Varnama, Vadodara, Gujarat, India 2BITS Institute of Pharmacy, Gujarat Technological University, Varnama, Vadodara, Gujarat, India. __________________________________________________________________________________ ABSTRACT Oral mucosal drug delivery is an alternative and promising method of systemic drug delivery which offers several advantages. Sublingual literally meaning is ''under the tongue'', administrating substance via mouth in such a way that the substance is rapidly absorbed via blood vessels under tongue. Sublingual route offers advantages such as bypasses hepatic first pass metabolic process which gives better bioavailability, rapid onset of action, patient compliance , self-medicated. Dysphagia (difficulty in swallowing) is common among in all ages of people and more in pediatric, geriatric, psychiatric patients. In terms of permeability, sublingual area of oral cavity is more permeable than buccal area which is in turn is more permeable than palatal area. Different techniques are used to formulate the sublingual dosage forms. Sublingual drug administration is applied in field of cardiovascular drugs, steroids, enzymes and some barbiturates. This review highlights advantages, disadvantages, different sublingual formulation such as tablets and films, evaluation. Key Words: Sublingual delivery, techniques, improved bioavailability, evaluation. INTRODUCTION and direct access to systemic circulation, the oral Drugs have been applied to the mucosa for topical mucosal route is suitable for drugs, which are application for many years. However, recently susceptible to acid hydrolysis in the stomach or there has been interest in exploiting the oral cavity which are extensively metabolized in the liver.
    [Show full text]
  • Liposome-Based Drug Delivery Systems in Cancer Immunotherapy
    pharmaceutics Review Liposome-Based Drug Delivery Systems in Cancer Immunotherapy Zili Gu 1 , Candido G. Da Silva 1 , Koen van der Maaden 2,3, Ferry Ossendorp 2 and Luis J. Cruz 1,* 1 Department of Radiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands 2 Tumor Immunology Group, Department of Immunology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands 3 TECOdevelopment GmbH, 53359 Rheinbach, Germany Received: 1 October 2020; Accepted: 2 November 2020; Published: 4 November 2020 Abstract: Cancer immunotherapy has shown remarkable progress in recent years. Nanocarriers, such as liposomes, have favorable advantages with the potential to further improve cancer immunotherapy and even stronger immune responses by improving cell type-specific delivery and enhancing drug efficacy. Liposomes can offer solutions to common problems faced by several cancer immunotherapies, including the following: (1) Vaccination: Liposomes can improve the delivery of antigens and other stimulatory molecules to antigen-presenting cells or T cells; (2) Tumor normalization: Liposomes can deliver drugs selectively to the tumor microenvironment to overcome the immune-suppressive state; (3) Rewiring of tumor signaling: Liposomes can be used for the delivery of specific drugs to specific cell types to correct or modulate pathways to facilitate better anti-tumor immune responses; (4) Combinational therapy: Liposomes are ideal vehicles for the simultaneous delivery of drugs to be combined with other therapies, including chemotherapy, radiotherapy, and phototherapy. In this review, different liposomal systems specifically developed for immunomodulation in cancer are summarized and discussed. Keywords: liposome; drug delivery; cancer immunotherapy; immunomodulation 1. The Potential of Immunotherapy for the Treatment of Cancer Cancer immunotherapy has been widely explored because of its durable and robust effects [1].
    [Show full text]
  • Intra-Luminal Focused Ultrasound for Augmentation of Gastrointestinal Drug Delivery
    Editorial Page 1 of 2 Intra-luminal focused ultrasound for augmentation of gastrointestinal drug delivery Ezekiel Maloney1, Joo Ha Hwang2 1Department of Radiology, 2Division of Gastroenterology, Department of Medicine, University of Washington, Seattle, WA, USA Correspondence to: Joo Ha Hwang, MD, PhD. Division of Gastroenterology, Department of Medicine, University of Washington, Box 359773, 325 Ninth Avenue, Seattle, WA 98104, USA. Email: [email protected]. Provenance: This is a Guest Editorial commissioned by Section Editor Hui Kong, MD, PhD (Department of Respiratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China). Comment on: Schoellhammer CM, Schroeder A, Maa R, et al. Ultrasound-mediated gastrointestinal drug delivery. Sci Transl Med 2015;7:310ra168. Submitted Feb 01, 2017. Accepted for publication Feb 06, 2017. doi: 10.21037/atm.2017.03.42 View this article at: http://dx.doi.org/10.21037/atm.2017.03.42 The recent article by Schoellhammer et al., “Ultrasound- intensity ultrasound frequencies followed by quantification mediated gastrointestinal drug delivery” primarily of delivery of permeants (e.g., glucose, dextran, insulin). addresses practical limitations in drug delivery for medical Treated tissues showed enhanced transport. Similar management of inflammatory bowel disease (IBD), and findings were demonstrated in small and large bowel tissue presents pre-clinical data demonstrating that intra- for radiolabeled mesalamine and hydrocortisone. With 1 luminal, sub-ablative focused ultrasound (FUS), delivered minute of ultrasound treatment time, 3–5-fold improved via a trans-rectal transducer, can overcome some of these drug delivery was observed versus control. Additional limitations (1). The clinical application and benefit of such a ex vivo experiments utilizing variable FUS protocols to device is clear.
    [Show full text]
  • Chapter 1 Controlling Drug Delivery
    chapter 1 Controlling drug delivery Overview In this chapter we will: & differentiate drug delivery systems according to their physical state & differentiate drug delivery systems according to their route of administration & differentiate drug delivery systems according to their type of drug release & discuss drug transport across epithelial barriers. Introduction KeyPoints & Continued developments in Pharmacotherapy can be defined as the treatment chemistry, molecular biology and prevention of illness and disease by means of and genomics support the drugs of chemical or biological origin. It ranks discovery and developments among the most important methods of medical of new drugs and new drug treatment, together with surgery, physical targets. & treatment, radiation and psychotherapy. There The drug delivery system are many success stories concerning the use of employed can control the pharmacological action of a drugs and vaccines in the treatment, prevention drug, influencing its and in some cases even eradication of diseases pharmacokinetic and (e.g. smallpox, which is currently the only subsequent therapeutic human infectious disease completely profile. eradicated). Although it is almost impossible to estimate the exact extent of the impact of pharmacotherapy on human health, there can be no doubt that pharmacotherapy, together with improved sanitation, better diet and better housing, has improved people’s health, life expectancy and quality of life. Tip Unprecedented developments in genomics Combinatorial chemistry is a way to and molecular biology today offer a plethora of build a variety of structurally related new drug targets. The use of modern chemical drug compounds rapidly and synthetic methods (such as combinatorial systematically. These are assembled chemistry) enables the syntheses of a large from a range of molecular entities number of new drug candidates in shorter times which are put together in different ‘ ’ than ever before.
    [Show full text]
  • TOXICOLOGY and EXPOSURE GUIDELINES ______(For Assistance, Please Contact EHS at (402) 472-4925, Or Visit Our Web Site At
    (Revised 1/03) TOXICOLOGY AND EXPOSURE GUIDELINES ______________________________________________________________________ (For assistance, please contact EHS at (402) 472-4925, or visit our web site at http://ehs.unl.edu/) "All substances are poisons; there is none which is not a poison. The right dose differentiates a poison and a remedy." This early observation concerning the toxicity of chemicals was made by Paracelsus (1493- 1541). The classic connotation of toxicology was "the science of poisons." Since that time, the science has expanded to encompass several disciplines. Toxicology is the study of the interaction between chemical agents and biological systems. While the subject of toxicology is quite complex, it is necessary to understand the basic concepts in order to make logical decisions concerning the protection of personnel from toxic injuries. Toxicity can be defined as the relative ability of a substance to cause adverse effects in living organisms. This "relative ability is dependent upon several conditions. As Paracelsus suggests, the quantity or the dose of the substance determines whether the effects of the chemical are toxic, nontoxic or beneficial. In addition to dose, other factors may also influence the toxicity of the compound such as the route of entry, duration and frequency of exposure, variations between different species (interspecies) and variations among members of the same species (intraspecies). To apply these principles to hazardous materials response, the routes by which chemicals enter the human body will be considered first. Knowledge of these routes will support the selection of personal protective equipment and the development of safety plans. The second section deals with dose-response relationships.
    [Show full text]
  • The Role of Deformable Liposome Characteristics on Skin Permeability of Meloxicam: Optimal Transfersome As Transdermal Delivery Carriers
    Send Orders for Reprints to [email protected] The Open Conference Proceedings Journal, 2013, 4, 87-92 87 Open Access The Role of Deformable Liposome Characteristics on Skin Permeability of Meloxicam: Optimal Transfersome as Transdermal Delivery Carriers Sureewan Duangjit1,2, Praneet Opanasopit1, Theerasak Rojarata1, Yasuko Obata2, Yoshinori Oniki2, Kozo Takayama2 and Tanasait Ngawhirunpat1,* 1Department of Pharmaceutical Technology, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand 2Department of Pharmaceutics, Hoshi University, Ebara 2-4-41, Shinagawa-ku, Tokyo 142-8501, Japan Abstract: The role of deformable liposomes characteristics on skin permeability has evoked considerable interest, since the articles reporting the effectiveness of transfersomes for skin delivery were increasingly published. Several reports focus on the effect of formulation factor which directly affected the transfersome’s skin permeability. However, the effect of formulation factors was not fully understood as the contradictory results. To clarify this problem, the reliable statistical techniques, excellent experimental design and systematical variation were used in this study. Transfersomes loaded meloxicam containing controlled amount of phosphatidylcholine (PC), cholesterol (Chol), type of surfactant (hydrophilic part, lipophilic part ) were prepared and investigated for the physicochemical characteristics (e.g., size, size distribution, charge, elasticity, drug content, morphology) and skin permeability. The results indicated
    [Show full text]
  • Biopharmaceutical Properties of Patches Relevant for Transdermal Drug Absorption – Confounding Factors and In‐Vitro Testing
    Biopharmaceutical Properties of Patches 16.06.2015 Relevant for Transdermal Drug Absorption Biopharmaceutical Properties of Patches Relevant for Transdermal Drug Absorption – Confounding Factors and In‐Vitro Testing Johannes Bartholomäus Pharmakreativ Consulting, Aachen Skin as Barrier to Transdermal Absorption And that’s from what Mother Nature did not design all the difficulties in transdermal drug skin as an absorption site. delivery arise. It‘s much more the opposite! Stratum corneum as lipophilic barrier June 16, 2015 J. Bartholomäus: Biopharmaceutical Properties of Patches 2 © Johannes Bartholomäus 1 Biopharmaceutical Properties of Patches 16.06.2015 Relevant for Transdermal Drug Absorption Definition TDDS by Guidelines . Transdermal drug delivery systems . Transdermal patch:** Flexible single‐ (TDDS):* A TDDS or transdermal dose preparation intended to be patch is a flexible pharmaceutical applied to the unbroken skin to preparation of varying size containing obtain a systemic delivery over an one or more active substance(s) to be extended period of time. applied on the intact skin for systemic . Transdermal patches consist of a availability. backing sheet supporting a reservoir . There are two main types of or a matrix containing the active transdermal patch systems substance(s) and on the top a depending on how the drug pressure‐sensitive adhesive, which substance is dispersed in other patch assures the adhesion of the components: preparation to the skin. – Matrix systems with drug release based on . The backing sheet is impermeable to the diffusion of drug substance. the active substance(s) and normally – Reservoir systems containing a specific liquid drug compartment and release is impermeable to water. controlled by a membrane.
    [Show full text]
  • Pulmonary Delivery of Biological Drugs
    pharmaceutics Review Pulmonary Delivery of Biological Drugs Wanling Liang 1,*, Harry W. Pan 1 , Driton Vllasaliu 2 and Jenny K. W. Lam 1 1 Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 21 Sassoon Road, Pokfulam, Hong Kong, China; [email protected] (H.W.P.); [email protected] (J.K.W.L.) 2 School of Cancer and Pharmaceutical Sciences, King’s College London, 150 Stamford Street, London SE1 9NH, UK; [email protected] * Correspondence: [email protected]; Tel.: +852-3917-9024 Received: 15 September 2020; Accepted: 20 October 2020; Published: 26 October 2020 Abstract: In the last decade, biological drugs have rapidly proliferated and have now become an important therapeutic modality. This is because of their high potency, high specificity and desirable safety profile. The majority of biological drugs are peptide- and protein-based therapeutics with poor oral bioavailability. They are normally administered by parenteral injection (with a very few exceptions). Pulmonary delivery is an attractive non-invasive alternative route of administration for local and systemic delivery of biologics with immense potential to treat various diseases, including diabetes, cystic fibrosis, respiratory viral infection and asthma, etc. The massive surface area and extensive vascularisation in the lungs enable rapid absorption and fast onset of action. Despite the benefits of pulmonary delivery, development of inhalable biological drug is a challenging task. There are various anatomical, physiological and immunological barriers that affect the therapeutic efficacy of inhaled formulations. This review assesses the characteristics of biological drugs and the barriers to pulmonary drug delivery.
    [Show full text]
  • Review On: Sublingual Route for Systemic Drug Delivery
    IAJPS 2018, 05 (01), 453-462 Himanshi Rathaur and G.Gnanarajan ISSN 2349-7750 CODEN [USA]: IAJPBB ISSN: 2349-7750 INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES http://doi.org/10.5281/zenodo.1161209 Available online at: http://www.iajps.com Review Article REVIEW ON: SUBLINGUAL ROUTE FOR SYSTEMIC DRUG DELIVERY Himanshi Rathaur*1and G.Gnanarajan2 *1Shri Guru Ram Rai Institute of Technology and Sciences, Department of Pharmaceutics, Uttarakhand Technical University, Dehradun,248001, Uttarakhand, India 2Shri Guru Ram Rai Institute of Technology and Sciences, Department of Pharmaceutics, Faculty of Pharmacy, Shri Guru Ram Rai University, Dehradun, Uttarakhand, India. Abstract: Delivery of drug in the oral cavity through the oral mucosa is examined to be a promising alternative to the oral route. Sublingual means “under the tongue” which rapidly absorb the drug through the oral mucosa and enter into the systemic circulation. This route provides various advantages such as quick onset of action, patient compliance, hepatic first pass metabolism and increase bioavailability. Dysphagia is a common problem in pediatric, geriatric and psychiatric patients. In terms of permeability sublingual area of oral cavity is more permeable than buccal area which is in turn is more permeable than palatal area. Now a days most of the population need effective, faster and better relief within a short period of time. So, this route is the most appropriate route of administration and it rapidly dissolves in saliva. Many drugs like cardiovascular drugs, steroids,
    [Show full text]
  • A Guide to Aerosol Delivery Devices for Respiratory Therapists 4Th Edition
    A Guide To Aerosol Delivery Devices for Respiratory Therapists 4th Edition Douglas S. Gardenhire, EdD, RRT-NPS, FAARC Dave Burnett, PhD, RRT, AE-C Shawna Strickland, PhD, RRT-NPS, RRT-ACCS, AE-C, FAARC Timothy R. Myers, MBA, RRT-NPS, FAARC Platinum Sponsor Copyright ©2017 by the American Association for Respiratory Care A Guide to Aerosol Delivery Devices for Respiratory Therapists, 4th Edition Douglas S. Gardenhire, EdD, RRT-NPS, FAARC Dave Burnett, PhD, RRT, AE-C Shawna Strickland, PhD, RRT-NPS, RRT-ACCS, AE-C, FAARC Timothy R. Myers, MBA, RRT-NPS, FAARC With a Foreword by Timothy R. Myers, MBA, RRT-NPS, FAARC Chief Business Officer American Association for Respiratory Care DISCLOSURE Douglas S. Gardenhire, EdD, RRT-NPS, FAARC has served as a consultant for the following companies: Westmed, Inc. and Boehringer Ingelheim. Produced by the American Association for Respiratory Care 2 A Guide to Aerosol Delivery Devices for Respiratory Therapists, 4th Edition American Association for Respiratory Care, © 2017 Foreward Aerosol therapy is considered to be one of the corner- any) benefit from their prescribed metered-dose inhalers, stones of respiratory therapy that exemplifies the nuances dry-powder inhalers, and nebulizers simply because they are of both the art and science of 21st century medicine. As not adequately trained or evaluated on their proper use. respiratory therapists are the only health care providers The combination of the right medication and the most who receive extensive formal education and who are tested optimal delivery device with the patient’s cognitive and for competency in aerosol therapy, the ability to manage physical abilities is the critical juncture where science inter- patients with both acute and chronic respiratory disease as sects with art.
    [Show full text]